Ajovy® (fremanezumab-vfrm)

BL 761089

Ajovy® (fremanezumab-vfrm)

BL 761089

U.S. License Holder:

Teva Pharms. USA

Date of License:

September-14-2018

Last Update:

May-23-2023

approved_indications FDA-Approved Indications

AJOVY (fremanezumab-vfrm) is a calcitonin gene-related peptide antagonist indicated for the preventive treatment of migraine in adults.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2018-01422

U.S. Patent No.
9,340,614 (Antagonist Antibodies Directed Against Calcitonin Gene-related Peptide and Methods Using Same)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Composition of Matter Formulation

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-1747

IPR Status
Final Written Decision (All Challenged Claims Found Unpatentable); Federal Circuit Appeal Affirmed

IPR2018-01423

U.S. Patent No.
9,266,951 (Antagonist Antibodies Directed Against Calcitonin Gene-related Peptide and Methods Using Same)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Composition of Matter Formulation

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-1748

IPR Status
Final Written Decision (All Challenged Claims Found Unpatentable); Federal Circuit Appeal Affirmed

IPR2018-01424

U.S. Patent No.
9,346,881 (Antagonist Antibodies Directed Against Calcitonin Gene-related Peptide and Methods Using Same)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Composition of Matter Formulation

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-1749

IPR Status
Final Written Decision (All Challenged Claims Found Unpatentable); Federal Circuit Appeal Affirmed

IPR2018-01425

U.S. Patent No.
9,890,210 (Antagonist Antibodies Directed Against Calcitonin Gene-related Peptide)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Composition of Matter

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-1750

IPR Status
Final Written Decision (All Challenged Claims Found Unpatentable); Federal Circuit Appeal Affirmed

IPR2018-01426

U.S. Patent No.
9,890,211 (Antagonist Antibodies Directed Against Calcitonin Gene-related Peptide)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Composition of Matter

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-1751

IPR Status
Final Written Decision (All Challenged Claims Found Unpatentable); Federal Circuit Appeal Affirmed

IPR2018-01427

U.S. Patent No.
8,597,649 (Antagonist Antibodies Directed Against Calcitonin Gene-related Peptide and Methods Using Same)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Composition of Matter Formulation

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-1752

IPR Status
Final Written Decision (All Challenged Claims Found Unpatentable); Federal Circuit Appeal Affirmed

IPR2018-01710

U.S. Patent No.
8,586,045 (Methods of Using Anti-CGRP Antagonist Antibodies)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-1876 (lead, consolidated with 20-1877 and 20-1878)

IPR Status
Final Written Decision (No Challenged Claims Found Unpatentable); Federal Circuit Appeal Affirmed

IPR2018-01711

U.S. Patent No.
9,884,907 (Methods for Treating Headache Using Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-1877 (consolidated with lead appeal 20-1876)

IPR Status
Final Written Decision (No Challenged Claims Found Unpatentable); Federal Circuit Appeal Affirmed

IPR2018-01712

U.S. Patent No.
9,884,908 (Methods for Treating Headache Using Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
20-1878 (consolidated with lead appeal 20-1876)

IPR Status
Final Written Decision (No Challenged Claims Found Unpatentable); Federal Circuit Appeal Affirmed

IPR2022-00738

U.S. Patent No.
11,028,160 (Treating Refractory Migraine)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted, Pending

IPR2022-00739

U.S. Patent No.
11,028,161 (Treating Refractory Migraine)

Patent Owner
Teva Pharmaceuticals International GmbH

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted, Pending

IPR2022-00796

U.S. Patent No.
10,392,434 (Treating Refractory Migraine)

Patent Owner
Teva Pharmaceuticals International GmbH; Teva Pharmaceuticals USA, Inc.

Petitioner(s)
Eli Lilly & Co.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

IPR Status
Instituted, Pending

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:17-cv-12087 (D. Mass.)

U.S. Patent Nos.
8,586,045 (Methods of Using Anti-CGRP Antagonist Antibodies) 8,597,649 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide and Methods Using Same) 9,266,951 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide and Methods Using Same) 9,340,614 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide and Methods Using Same) 9,346,881 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide and Methods Using Same)

Plaintiffs
Teva Pharmaceuticals International GmbH, Teva Pharmaceuticals USA, Inc.

Defendants
Eli Lilly & Co.

Status
Dismissed

BPCIA
N

1:18-cv-10242 (D. Mass.)

U.S. Patent Nos.
9,884,907 (Methods for Treating Headache Using Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide) 9,884,908 (Methods for Treating Headache Using Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide) 9,890,210 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide) 9,890,211 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide)

Plaintiffs
Teva Pharmaceuticals International GmbH; Teva Pharmaceuticals USA, Inc.

Defendants
Eli Lilly & Co.

Status
Dismissed

BPCIA
N

1:18-cv-12029 (D. Mass.)

U.S. Patent Nos.
8,586,045 (Methods of Using Anti-CGRP Antagonist Antibodies) 8,597,649 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide and Methods Using Same) 9,266,951 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide and Methods Using Same) 9,340,614 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide and Methods Using Same) 9,346,881 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide and Methods Using Same) 9,884,907 (Methods for Treating Headache Using Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide) 9,884,908 (Methods for Treating Headache Using Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide) 9,890,210 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide) 9,890,211 (Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide)

Plaintiffs
Teva Pharmaceuticals International GmbH, Teva Pharmaceuticals USA, Inc.

Defendants
Eli Lilly & Co.

Status
Jury Verdict (Claims Valid and Infringed)

BPCIA
N

1:21-cv-10954 (D. Mass.)

U.S. Patent Nos.
11,028,160 (Treating Refractory Migraine) 11,028,161 (Treating Refractory Migraine)

Plaintiffs
Teva Pharmaceuticals International GmbH, Teva Pharmaceuticals USA, Inc.

Defendants
Eli Lilly & Co.

Status
Stayed Pending IPRs

BPCIA
N

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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